NCT00553306

Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma

Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with aldesleukin after cyclophosphamide may be an effective treatment for melanoma. PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T cells together with aldesleukin after cyclophosphamide and to see how well they work in treating patients with stage IV melanoma.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients using autologous CD4+ and CD8+ antigen-specific T cell clones. II. To evaluate the antitumor effects of CD4+ and CD8+ antigen-specific T cells in patients with metastatic melanoma. III. To determine the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells. SECONDARY OBJECTIVES: I. To assess the in vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T cells. OUTLINE: This is a phase I study followed by a phase II study. Beginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2 hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up weekly for 8 weeks, and then periodically thereafter.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic autologous lymphocytes	Given IV
BIOLOGICAL	aldesleukin	Given subcutaneously
DRUG	cyclophosphamide	Given IV
PROCEDURE	biopsy	Optional correlative studies
OTHER	immunohistochemistry staining method	Optional correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-08-01
• Completion: 2012-03-01
• First posted: 2007-11-05
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States